ORIGINAL ARTICLE

Comparison of the Efficacy of Combination Therapy of Prednisolone Acyclovir with Prednisolone Alone in Bells Palsy

How to Cite This Article: Khajeh A, Fayyazi A, Soleimani Gh, Miri-Aliabad Gh, Shaykh Veisi S, Khajeh B. Comparison of the Efficacy of
Combination Therapy of Prednisolone - Acyclovir with Prednisolone Alone in Bells Palsy. Iran J Child Neurol. Spring 2015; 9(2):17-20.

Abstract
Ali KHAJEH MD ,
Afshin FAYYAZI MD2,
Gholamreza Soleimani MD1,
Ghasem MIRI-ALIABAD MD1,
Sara SHAYKH VEISI MD3,
Behrouz KHAJEH MD4
1

1. Department of Pediatrics, Children

and Adolescent Health Research
Center, Zahedan University of Medical
Sciences, Zahedan, Iran.
2. Department of Pediatrics, Hamedan
University of Medical Sciences,
Hamedan, Iran.
3. General Physician, Zahedan
University of Medical Sciences,
Zahedan, Iran.
4. Student of Pharmacy , Zabol
University of Medical Science , Zabol,
Iran
Corresponding Author:
Miri-Aliabad Gh.
Department of Pediatrica,
Children & Adolescent Health
Research Center, Zahedan University of
Medical Sciences, Zahedan, Iran
Tel: + 98 5433295575
Email: gh_miri@yahoo.com

Received:24-Feb-2014
Last revised:26- Jan-2014
Accepted: 29-Jul-2014

Objective
Bells palsy is a rapid onset, usually, unilateral paralysis of the facial nerve that
causes significant changes in an individuals life such as a decline in personal,
social, and educational performance. This study compared efficacy of combined
prednisolone and acyclovir therapy with prednisolone alone.
Materials & Methods
This study is a randomized controlled trial conducted on 43 Children (218 years
old) with Bells palsy. The first group of 23 patients was treated with prednisolone
and the remaining patients were treated with a combination of prednisolone and
acyclovir. The required data were extracted, using an informational form based
on the House-Brackmann Scale, which grades facial nerve paralysis. The data
were analyzed with Mann-Whitney test using SPSS version 16.
Results
The mean age of the first and second group were 8.65 5.07 and 8.35 4.92
years, respectively, (p=0.84). Sixty one percent and 39% of patients in the first
group, and 45% and 55% of patients in the second group were male and female,
respectively. No significant differences exist between the groups in terms of age
and gender. The rate of complete recovery was 65.2% in group I and 90% in the
group II (p=0.04).
Conclusion
The results of this study showed that the combined prednisolone and acyclovir
therapy of patients with Bells palsy is far more effective than treatment with
prednisolone alone. Actually, age and gender had no impact on the rate of
recovery.

Keywords: Bells palsy; Prednisolone; Acyclovir; Children

Introduction
Bells palsy is a rapid onset, idiopathic facial nerve paralysis with an incidence rate
of 20 per 100,000 per year (1). Facial paralysis can range from mild to complete
paralysis and can improve within a year (2). The incidence rate is equal in both
genders, occurs at any age, and both sides may be affected equally (3). Bells palsy
is uncommon in children less than two years of age and a thorough examination
should be performed to find out the reason for it (2). Despite uncertainty of the actual
mechanisms of the disease and it may arise due to inflammation along the labyrinth
of facial nerve bony canal that results in compression and demyelination of axon

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Comparison of the Efficacy of Combination Therapy of Prednisolone - Acyclovir with Prednisolone Alone in Bells Palsy

and impairment of nerve blood flow (4). Genetic factors,

vascular ischemia, inflammatory factors secondary to
viral infections, and autoimmune disorders are proposed
as the underlying causes of Bells palsy. However, its
cause is still unknown (5). Many viruses, including HIV,
EBV, and HBV are suspected as triggering organisms,
but HSV is the most involved (6). The main clinical
symptom of Bells palsy is facial motor dysfunction (5).
Patients complain typically about weakness or complete
paralysis of all muscles on one side of the face. A lack of
complete recovery of facial symmetry in the long term
potentially affects the quality of life such as difficulty
in drinking, eating, talking, and psychosocial problems,
and creates a remarkable disruption in social activities
(2, 7). The disease prognosis is good and almost 70% of
patients recover completely within 6 months of treatment,
though 30% of patients get residual symptoms, such as
paresis, contracture, and face spasms or synkinesis (7).
Treatment of these patients is controversial and variable
(8). Prednisone and acyclovir are widely used separately
or in combination; however, their effectiveness has
been weakly evidenced (9, 10). Although there is no
treatment of choice for this disease, corticosteroids
are widely prescribed as the initial treatment of Bells
palsy to reduce swelling and inflammation of the facial
nerve (1, 5). The effects of antiviral therapies in Bells
palsy are not confirmed so far and the question whether
adding antiviral therapy to other treatments, such as
corticosteroid therapy, can improve the disease better
and faster than corticosteroids alone (1). Nevertheless,
given the possible association of Bells palsy with viral
infections such as HSV, antiviral therapy seems logical
(5, 11). This study compares the efficiency and efficacy
of acyclovir, prednisolone separately; and in combination
in the treatment of Bells palsy in children.

Materials & Methods

This study was performed as a randomized controlled
trial (RCT). Forty-three patients with acute unilateral
peripheral facial palsy with an age range of 218 years
were enrolled in the study. Exclusion criteria included
patients with paralysis of other cranial nerves, passing
more than 3 days of symptoms onset, patients with less
than 2 years of age and older than 18 years, presence
of secondary causes of the 7th nerve palsy, suspicion of

18

meningitis, vasculopathy, Ramsey Hunt syndrome, peptic

ulcer, anti-herpetic treatment within the last 2 weeks, and
sensitivity to acyclovir. The first group received 2 mg/
kg/day prednisolone, and the second group was treated
with a combination of 2 mg/kg/day prednisolone and 10
mg/kg acyclovir every 8 hours for 7 days. In suspected
cases, patients were examined to rule out other causes of
the 7th nerve palsy, and imaging studies revealed a CP
angle tumor in a patient with Bells palsy who was then
excluded from the study. Informed consent was obtained
from parents of children. This study was approved by the
ethics committee of the University.
The required data were extracted using an informational
form based on the House-Brackmann Scale (12),
which grades facial nerve paralysis. The patients were
reassessed in terms of recovery rate at the end of the
first and third months of treatment. Based on the HouseBrackmann criteria, the response to treatment are graded
as complete recovery (grade 1), partial recovery (grade
25), and no response (grade 6). The data were analyzed
using SPSS (ver 16) through comparing the efficacy
of the two treatment regimens with Mann-Whitney
and Fishers exact tests. P-value less than 0.05 were
considered significant.

Results
Table 1 depicts the demographic characteristics of
patients. Among the 43 patients with Bells palsy in this
study, 23 patients were treated with prednisolone and 20
patients with combination of prednisolone and acyclovir.
There were no noteworthy differences in case of age and
gender between the two groups (p > 0.05).
Table 1. Frequency of Bells palsy Patients according
to the Age and Gender in Two Groups
Prednisolone
Group

Combined
Group

Male

14(61 %)

9(45%)

Female

9(39% )

11(55% )

8.655.07

8.354.92

Group

Gender

Mean age (yr)

P-Value

0.29
0.84

Table 2 shows the treatment results. According to this,

it can be concluded that the rate of recovery in patients
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Comparison of the Efficacy of Combination Therapy of Prednisolone - Acyclovir with Prednisolone Alone in Bells Palsy

with Bells palsy treated with combined prednisolone

and acyclovir was much more than that of prednisolone
therapy alone(p = 0.04) and had lower sequels after
treatment.
Table 2. Comparison of The Recovery Rate of Bells
Palsy in Prednisolone Group and Combined Treatment
Group
Group

Prednisolone
Group

Combined
Group

Complete

15(65.2%)

18(90%)

Partial

6(26.1%)

2(10%)

No response

2(8.7%)

0(0%)

P-Value

0.04

Discussion
There is no consensus on how to treat Bells palsy. In
our study, the rate of complete recovery was 65.2%
and 90% in patients who received prednisolone alone
and in those who received prednisolone and acyclovir,
respectively (p = 0.04). Several studies have shown
higher performance and greater improvement rate of
combination therapy of prednisolone and acyclovir
compared with prednisolone alone (13-16). Another
study also demonstrated that patients with Bells palsy
who were treated with prednisolone and valacyclovir
expressed better results and improvement than with any
treatment (17). In a study by Hato et al., the recovery rate
in patients treated with valacyclovir and prednisolone
was higher than for patients treated with prednisolone
alone. This outcome is consistent with the results of our
study (18). Rosenblum R indicated better results were
obtained when adding antiviral agents to corticosteroids
for treating Bells palsy (19). Moreover, a combination
of prednisolone and famciclovir was more effective than
prednisolone alone in the treatment of Bells palsy and
a significant number of patients improved by adding
famciclovir (20). Adding an antivirus to the treatment
of Bells palsy is because of HSV involvement in facial
nerve inflammation. In fact, antiviruses eradicate the
virus while corticosteroid reduced nerve swelling (21).
However, other studies that underestimate the efficacy
of treatment by acyclovir as follows. In a double blind,
placebo-controlled, randomized study, early treatment

Iran J Child Neurol. 2015 Spring Vol 9 No 2

with prednisolone significantly improved Bells palsy.

However, no significant advantage was found for
acyclovir alone or in combination with prednisolone
(22). Kawagachi et al. showed that the reactivation
of VZV, HSV-1 in 34% of patients with Bells palsy,
and the recovery rate in patients receiving combined
prednisolone and valacyclovir was significantlyy greater
than prednisolone alone (23). In a meta-analysis, results
of antiviral therapy were remarkably worse than for
corticosteroids (n = 768, RR 2.82, 95% CI 1.09 to 7.32),
while the results of antiviral and corticosteroid therapy
were significantly better than a placebo (n = 658, RR
0.56, 95% CI 0.41 to 0.76) (21). Meyer showed that the
effect of corticosteroids in the treatment of Bells palsy,
despite adding antivirals, is remarkable (24). Another
study concluded that steroids are effective in patients
whose Bells palsy is started recently, and that antiviral
therapy does not significantly improved the facial nerve
function (25). Numthavaj et al. inferred that the recovery
rate with combination therapy increases only slightly and
that prednisolone is the basis of Bells palsy treatment
(1). As maintained by the results of this study and other
similar studies, combination therapy, especially in severe
cases of Bells palsy, is more effective than prednisolone
alone and results in more complete recovery of facial
paralysis and reduction of its complications. However,
some studies have not indicated further merits for
adding antiviral agents to corticosteroids. This could
be due to several factors. Also, our study was different
in consumption of antiviral agents, sample size, patient
age, and different inclusion and exclusion criteria in
comparison of other studies.
Conflict of interest: the authors have nothing to disclose.

Acknowledgment
The authors wish to thank all patients participated in this
study as well as all nurses in the pediatric ward.
Author Contribution
Ali Khajeh: Study concepts and design, Gholamreza
Soleimani: Literature search, Ghasem Miri-Aliabad:
Clinical studies, Data analysis. Statistical analysis,
Manuscript preparation. Afshin Fayazi: Manuscript
editing, Sara Shaykh Veisi: Data acquisition,Behrooz
Khajeh: Manuscript review.

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Comparison of the Efficacy of Combination Therapy of Prednisolone - Acyclovir with Prednisolone Alone in Bells Palsy

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